Dataset Information

Self-administered Acupressure for Persistent Cancer-related Fatigue: Fidelity Considerations.

ABSTRACT:

Context

Complementary therapies are frequently used by breast cancer patients for symptom management; however, documentation of the components of intervention fidelity for studies is not widely available.

Objective

This report examines the components of intervention fidelity, as put forth by the Treatment Fidelity Workgroup of the Behavior Change Consortium at the National Institutes for Health (NIH-BCC Workgroup), within an ongoing acupressure study of breast cancer survivors with persistent cancer-related fatigue (PCRF).

Design

For the acupressure study, the research team designed a randomized, controlled trial (RCT) with 3 parallel groups: (1) stimulating acupressure (intervention group); (2) relaxing acupressure (intervention group); and (3) standard care (control group).

Setting

At baseline and at wk 3 and wk 6 of the study, women in the acupressure study attended sessions for training and data collection at clinics in the counties of Michigan where they lived. The self-administration of acupressure occurred in participants' homes.

Participants

Targeted enrollment for the acupressure study is 300 breast cancer survivors who had experienced moderate-to-severe PCRF lasting longer than 1 y beyond treatment. The women are being recruited from 5 counties in Michigan, using the Michigan Tumor Registry to identify potential participants. The subsample report includes 183 participants who have completed all 10 wk of the acupressure study. Most participants in the acupressure study are Caucasian, are married, and have some college education.

Intervention

The acupressure study's educators teach participants in the intervention groups to self-administer either relaxing or stimulating acupressure for a 30-min period on a daily basis for 6 wk. All 3 groups receive the usual care for breast cancer survivors.

Outcome measures

For the acupressure study, the participants log the frequency of the self-administered acupressure sessions and their fatigue levels. Symptom assessments are made for all groups by telephone in the acupressure study at wk 2 through wk 5 to assess fatigue. A competency checklist is used at each session of training and retraining of both acupressure educators and participants. For this report, the 5 recommended fidelity components for interventions are (1) dose, (2) training, (3) intervention delivery, (4) intervention receipt, and (5) enactment of the intervention.

Results

The ongoing RCT incorporated all 5 components of fidelity and can serve as a model for future work in this area.

Conclusions

Research protocols that address intervention fidelity can provide results that support internal and external validity. Clinicians should consider recommending complementary interventions that have incorporated fidelity components into their efficacy testing.

SUBMITTER: Wyatt GK

PROVIDER: S-EPMC7841851 | biostudies-literature | 2015 Jul-Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Self-administered Acupressure for Persistent Cancer-related Fatigue: Fidelity Considerations.

Wyatt Gwen Karilyn GK Frambes Dawn Annette DA Harris Richard E RE Arnedt John Todd JT Murphy Susan L SL Zick Suzanna M SM

Alternative therapies in health and medicine 20150701 4

<h4>Context</h4>Complementary therapies are frequently used by breast cancer patients for symptom management; however, documentation of the components of intervention fidelity for studies is not widely available.<h4>Objective</h4>This report examines the components of intervention fidelity, as put forth by the Treatment Fidelity Workgroup of the Behavior Change Consortium at the National Institutes for Health (NIH-BCC Workgroup), within an ongoing acupressure study of breast cancer survivors wit ...[more]

PMID: 26030112

Similar Datasets

Project description:Despite high levels of clinically significant persistent cancer related fatigue in breast cancer survivors few treatments are currently available and most pose a significant burden on the part of the woman. Acupressure, a component of Traditional Chinese Medicine, has been shown to decrease fatigue levels by as much as 70% in cancer survivors while being inexpensive, non-toxic and an easy to use intervention. The primary aim of this study was to determine the efficacy of two types of self-administered acupressure (relaxation acupressure and stimulating acupressure), compared to standard of care on fatigue severity. Secondary aims were to evaluate the efficacy of two types of acupressure on sleep and kinetic parameters required for implementation of acupressure in a clinical setting; The purpose of this paper is to share the methodology used including challenges and insights.This study is a three group, randomized clinical trial. 375 breast cancer survivors at least 12 months after completion of cancer treatments, with moderate to severe persistent fatigue, are being randomized to one of 3 groups: self-administered relaxation acupressure; self-administered stimulating acupressure; or standard of care. Participants are assessed at baseline, 3 weeks, and 6 weeks followed by a 4-week follow-up period. The primary aim is to examine the effect of 6-weeks of relaxation acupressure compared to stimulatory acupressure or standard of care on fatigue as assessed by: weekly self-report using the Brief Fatigue Inventory; objective daytime physical activity on actigraph; or fatigue patterns assessed 4-times daily using a visual analog scale. Secondary endpoints include depression, anxiety, self-efficacy, and sleep quality.This study has the potential to develop a low-cost, self-care intervention for the most troubling of late-term effects in breast cancer populations, fatigue. The methods used may lend constructive ideas to other investigators working with this population and/or intervention.ClinicalTrial.Gov Trials Register NCT01281904.

Project description:Tobacco smoking is still a worldwide health risk. Current pharmacotherapies have at best, a success rate of no more than 50%. Auricular (ear) acupressure has been purported to be beneficial in achieving smoking cessation in some studies, while in others has been deemed insignificant. We hereby describe the protocol for a three-arm randomised controlled trial to examine the possible benefits of self-administered acupressure for smoking cessation.Sixty consenting participants with confirmed habit of tobacco smoking will be recruited and randomized into three arms to receive either auricular acupressure at five true acupoints (NADA protocol), auricular acupressure at five sham points, or no auricular acupressure at all. Participants having auricular acupressure will exert firm pressure to each acupoint bilaterally via the bead in the attached plasters whenever they feel the urge to smoke. The treatment phase will last for six weeks during which all participants will be assessed weekly to review their smoking log, state of abstinence, end-exhalation carbon monoxide levels and possible adverse effects including withdrawal reactions and stress levels. At any time, a successful quit date will be defined with continuous abstinence for the following consecutive 7 days. From then on, participants will be evaluated individually for continuous abstinence rate (CAR), end-exhalation carbon monoxide levels and adverse effects of stress and withdrawal at specified intervals up to 26 weeks. Expectancy of treatment will be assessed with a four-item Borkovec and Nau self-assessment credibility scale during and after intervention.We incorporate validated outcome measures of smoking cessation into our randomised controlled trial design with the objectives to evaluate the feasibility and possible benefits of self-administered auricular acupressure as a non-invasive alternative to pharmacotherapy for smoking cessation.ClinicalTrials.gov: NCT01389622 (registered Jul 7 2011).

Project description:There is an estimated 3 million women in the US living as breast cancer survivors and persistent cancer related fatigue (PCRF) disrupts the lives of an estimated 30% of these women. PCRF is associated with decreased quality of life, decreased sleep quality, impaired cognition and depression. The mechanisms of cancer related fatigue are not well understood; however, preliminary findings indicate dysfunctional activity in the brain as a potential factor. Here we investigate the relationship between PCRF on intrinsic resting state connectivity in this population. Twenty-three age matched breast cancer survivors (15 fatigued and 8 non-fatigued) who completed all cancer-related treatments at least 12 weeks prior to the study, were recruited to undergo functional connectivity magnetic resonance imaging (fcMRI). Intrinsic resting state networks were examined with both seed based and independent component analysis methods. Comparisons of brain connectivity patterns between groups as well as correlations with self-reported fatigue symptoms were performed. Fatigued patients displayed greater left inferior parietal lobule to superior frontal gyrus connectivity as compared to non-fatigued patients (P < 0.05 FDR corrected). This enhanced connectivity was associated with increased physical fatigue (P = 0.04, r = 0.52) and poor sleep quality (P = 0.04, r = 0.52) in the fatigued group. In contrast greater connectivity in the non-fatigued group was found between the right precuneus to the periaqueductal gray as well as the left IPL to subgenual cortex (P < 0.05 FDR corrected). Mental fatigue scores were associated with greater default mode network (DMN) connectivity to the superior frontal gyrus (P = 0.05 FDR corrected) among fatigued subjects (r = 0.82) and less connectivity in the non-fatigued group (r = -0.88). These findings indicate that there is enhanced intrinsic DMN connectivity to the frontal gyrus in breast cancer survivors with persistent fatigue. As the DMN is a network involved in self-referential thinking we speculate that enhanced connectivity between the DMN and the frontal gyrus may be related to mental fatigue and poor sleep quality. In contrast, enhanced connectivity between the DMN and regions in the subgenual cingulate and brainstem may serve a protective function in the non-fatigued group.

Project description:BackgroundObesity is a common global health problem and increases the risk of many chronic illnesses. Given the adverse effects of antiobesity agents and bariatric surgeries, the exploration of noninvasive and nonpharmacological complementary methods for weight reduction is warranted.ObjectiveThe study aimed to determine whether self-administered auricular acupressure (AA) integrated with a smartphone app was more effective than using AA alone or the controls for weight reduction.MethodsThis study is a 3-arm randomized waitlist-controlled feasibility trial. A total of 59 eligible participants were randomly divided into either group 1 (AA group, n=19), group 2 (AA plus smartphone app, n=19), or group 3 (waitlist control, n=21). A total of 6 reflective zones or acupoints for weight reduction were chosen. The smartphone app could send out daily messages to the subjects to remind them to perform self-pressing on the 6 ear acupoints. A "date picker" of the 8-week treatment course was used to enable the users to input the compliance of pressing and the number of bowel movement daily instead of using the booklet for recordings. The app also served as a reminder for the subjects regarding the dates for returning to the center for acupoint changing and assessments. Treatment was delivered 2 times a week, for 8 weeks. Generalized estimating equations were used to examine the interactions among the groups before and after intervention.ResultsSubjects in group 2 expressed that the smartphone app was useful (7.41 out of 10). The most popular features were the daily reminders for performing self-pressing (88%), the ear diagram indicating the locations and functions of the 6 ear points (71%), and ear pressing method demonstrated in the video scripts (47%). Nearly 90% of the participants completed the 8-week intervention, with a high satisfaction toward the overall arrangement (8.37 out of 10). The subjects in group 1 and 2 achieved better therapeutic effects in terms of body weight, body mass index (BMI), waist circumference, and hip circumference and perceived more fullness before meals than the waitlist controls. Although no significant differences in the pairwise comparisons between the 2 groups were detected (P>.05), the decrease in body weight, BMI, body fat, visceral fat rating and leptin level, and increase in adiponectin level were notable in group 2 before and after the intervention.ConclusionsThe high compliance rate and high satisfaction toward the trial arrangement indicate that AA can be used to achieve weight reduction and applied in future large-scale studies. AA integrated with the smartphone app has a more notable effect than using AA alone for weight reduction. Larger sample size should be considered in future trials to determine the causal relationship between treatment and effect.Trial registrationClinicalTrials.gov NCT03442712; https://clinicaltrials.gov/ct2/show/NCT03442712 (Archived by WebCite at http://www.webcitation.org/78L2tO8Ql).

Project description:BackgroundAllergic rhinitis (AR) is an IgE-mediated inflammatory disease. Current conventional therapies for AR are unsatisfactory. Acupuncture has been recommended as an optional treatment for AR patients who are interested in non-pharmacotherapy in the new clinical practice guidelines for AR. Acupressure is a sub-type of acupuncture which is non-invasive with a low risk and can be self-administered. However, the current limited evidence is compromised by the high risk of bias and heterogeneity of methodology. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. This proposed RCT aims to evaluate the efficacy and safety of self-administered acupressure for the management of AR.Methods/designWe have designed a randomized, single-blind, non-specific controlled, two-arm, parallel clinical trial involving a 2-week run-in period, a 4-week intervention period and an 8-week follow-up period. The eligible participants will be randomized into either a specific or a non-specific acupressure group. They will be required to perform self-administered acupressure on either five specific acupressure points or five non-specific acupressure points, 1 min for each point, twice a day for 4?weeks. Participants will be asked to complete self-administered questionnaires for outcome measures including a 7-point scale of symptom severity, the Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQs), relief medication scores, adverse events and participants' opinion of this study at the different assessment points throughout the trial period. Data will be analyzed by the chi-square or t test using Statistical Package for Social Science (SPSS) software.DiscussionThe findings from this study should provide scientific evidence for the efficacy and safety of self-administered acupressure for the management of AR. This study may assist the development of a non-cost, non-invasive self-management method for AR sufferers.Trial registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR), ID: ACTRN12617001106325 Registered on 28 July 2017.

Project description:BackgroundCaregiving can be stressful, potentially creating physical and psychological strain. Substantial evidence has shown that family caregivers suffer from significant health problems arising from the demands of caregiving. Although there are programs supporting caregivers, there is little evidence regarding their effectiveness. Acupressure is an ancient Chinese healing method designed to restore the flow of Qi (vital energy) by applying external pressure to acupoints. A randomized, wait-list controlled trial was developed to evaluate the effectiveness of a self-administered acupressure intervention on caregiver stress (primary objective) and stress-related symptoms of fatigue, insomnia, depression, and health-related quality of life (secondary objectives) in Chinese caregivers of older family members.MethodsTwo hundred Chinese participants, aged ≥ 21 years, who are the primary caregivers of an older family member and screen positive for caregiver stress and symptoms of fatigue/insomnia/depression will be recruited from a community setting in Hong Kong. Subjects will be randomized to receive either an immediate treatment condition (self-administered acupressure intervention) or a wait-list control condition. The self-administered acupressure intervention will include (i) an individual learning and practice session twice a week for 2 weeks, (ii) a home follow-up visit once a week for 2 weeks, and (iii) 15-min self-practice twice a day for 6 weeks. The wait-list control group will receive the same acupressure training after the intervention group has completed the intervention. We hypothesize that Chinese family caregivers in the intervention group will have lower levels of caregiver stress, fatigue, insomnia, depression, and higher health-related quality of life after completion of the intervention than participants in the wait-list control group.DiscussionThis study will provide evidence for the effectiveness of self-administered acupressure in reducing stress and improving symptoms of fatigue, insomnia, depression, and health-related quality of life in Chinese family caregivers. The findings will inform the design of interventions to relieve negative health effects of caregiving. Furthermore, the results can raise community awareness and serve as a basis for policymaking, planning, and allocation of resources regarding empowerment of family caregivers for self-care.Trial registrationCurrent Controlled Trials NCT02526446 . Registered August 10, 2015.

Project description:RationaleRelationship dissatisfaction has been linked with worse health outcomes in many patient populations, though the mechanism(s) underlying this effect are unclear. Among patients with chronic fatigue syndrome (CFS) and their partners, there is evidence for a bi-directional association between poorer relationship satisfaction and the severity of CFS-related fatigue.ObjectiveHere, we hypothesized that relationship dissatisfaction negatively impacts fatigue severity through greater depression and less patient satisfaction about communication about symptoms to partners.MethodBaseline data were drawn from diagnosed CFS patients (N = 150) participating in a trial testing the efficacy of a stress management intervention. Data derived from fatigue severity (Fatigue Symptom Index, FSI), depression (Center for Epidemiologic Survey-Depression, CES-D), relationship quality (Dyadic Adjustment Scale, DAS) and communication satisfaction (Patient Symptom Disclosure Satisfaction, PSDS) questionnaires were used for bootstrapped indirect effect analyses using parallel mediation structural equation modeling in Mplus (v8). Age and BMI were entered as covariates.ResultsGreater relationship satisfaction predicted greater communication satisfaction (p < 0.01) and lower CES-D scores (p < 0.01), which in turn were each significantly related to greater fatigue severity (p < 0.05). Tests of the indirect paths indicated that relationship satisfaction had a significant effect on fatigue severity through both constructs, but primarily via depression. There was no direct association between relationship satisfaction and fatigue severity after the intermediate variables (depression, communication satisfaction) were included in the model.ConclusionResults highlight the importance of considering depression and communication-related factors when examining the effects of relationship satisfaction on CFS symptoms such as fatigue. Further mechanism-based, longitudinal research might identify relationship-related mediating variables that can be targeted therapeutically.

Project description:BackgroundRespiratory tract infection (RTI) is associated with a higher risk of kidney failure in patients with chronic kidney disease (CKD), without effective precautions. Self-administered acupressure (SAA) has been shown to potentially prevent RTI, but still lack of clinical evidence in CKD. The present randomized controlled trial assessed the efficacy and safety of SAA in preventing RTI recurrence in patients with CKD.MethodsParticipants with CKD who had been diagnosed with RTI on more than 2 occasions in the preceding 12 months were enrolled between November 6, 2017, and August, 6, 2018. They were randomly assigned (1:1) to receive daily SAA combined with usual care (intervention) or usual care alone (control) for 24 months. The primary outcome was time to first RTI. Secondary outcomes were RTI rate, kidney function, proteinuria and serum immune indicators, detected by the clinical laboratory in the hospital. The study would be discontinued if the participant met the criteria of stopping the study. Kaplan-Meier method and multivariable Cox proportional hazards regression were used to compare the primary outcome between the two groups.ResultsAmong the 540 patients screened, 114 participants were randomly assigned to the intervention group (n=57) or the control group (n=57). The median follow-up duration was 24.4 months. Compared with controls, participants in the intervention group did not have a significantly lower risk of RTI according to Kaplan-Meier analysis, but did have a significantly lower risk of RTI according to competing risk analysis (HR 0.65, 95% CI: 0.42-1.00; P=0.05), when considering endpoint (dialysis or death) and loss to follow-up as competing risks, and had a significantly lower rate of RTI [1.65 vs. 2.19 episodes per patient-year, respectively; incidence rate ratio (IRR) 0.75, 95% CI: 0.62-0.92; P=0.006]. Apart from lower study serum IgG levels in the intervention group at 24 months (mean difference 0.68 g/L; 95% CI: 0.07-1.29; P=0.029), all other secondary outcomes and overall adverse events were comparable between the 2 groups.ConclusionsSAA is a promising effective and safe therapy for preventing RTI in patients with CKD. However, the efficacy of SAA in children and adolescents still needs further study.Trial registrationChinese Clinical Trials Registry identifier: ChiCTR-IOR-17012654.

Dataset Information

Self-administered Acupressure for Persistent Cancer-related Fatigue: Fidelity Considerations.

Context

Objective

Design

Setting

Participants

Intervention

Outcome measures

Results

Conclusions

Publications

Self-administered Acupressure for Persistent Cancer-related Fatigue: Fidelity Considerations.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets